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Pragmatic Free Trial Meta

Pragmatic Free Trail Meta is an open data platform that enables research into pragmatic trials. It shares clean trial data and ratings using PRECIS-2, permitting multiple and varied meta-epidemiological studies that examine the effects of treatment across trials that employ different levels of pragmatism and other design features.

Background

Pragmatic studies provide real-world evidence that can be used to make clinical decisions. The term "pragmatic", however, is a word that is often used in contradiction and its definition and assessment require clarification. The purpose of pragmatic trials is to guide clinical practices and policy decisions rather than confirm a physiological hypothesis or clinical hypothesis. A pragmatic study should strive to be as close as is possible to actual clinical practices which include the recruiting participants, setting, design, delivery and execution of interventions, determining and analysis results, as well as primary analyses. This is a major distinction between explanation-based trials, as described by Schwartz and Lellouch1 which are designed to test the hypothesis in a more thorough manner.

Studies that are truly practical should avoid attempting to blind participants or clinicians as this could result in bias in estimates of treatment effects. The pragmatic trials also include patients from various health care settings to ensure that their results can be generalized to the real world.

Additionally, clinical trials should concentrate on outcomes that are important to patients, 프라그마틱 슬롯무료 like quality of life and functional recovery. This is especially important when trials involve the use of invasive procedures or could have dangerous adverse consequences. The CRASH trial29 compared a 2 page report with an electronic monitoring system for patients in hospitals suffering from chronic cardiac failure. The trial with a catheter, on the other hand was based on symptomatic catheter-related urinary tract infection as the primary outcome.

In addition to these features the pragmatic trial should also reduce the trial procedures and data collection requirements to reduce costs. Additionally these trials should strive to make their results as relevant to real-world clinical practice as is possible. This can be achieved by ensuring their primary analysis is based on the intention-to treat method (as defined in CONSORT extensions).

Many RCTs which do not meet the requirements for pragmatism however, they have characteristics that are contrary to pragmatism, have been published in journals of various types and incorrectly labeled pragmatic. This could lead to misleading claims of pragmatism, and 프라그마틱 슬롯 환수율 the usage of the term must be standardized. The creation of a PRECIS-2 tool that offers a standardized objective evaluation of the pragmatic characteristics is a good start.

Methods

In a pragmatic research study the aim is to inform clinical or policy decisions by demonstrating how an intervention could be integrated into routine care in real-world situations. Explanatory trials test hypotheses concerning the cause-effect relationship within idealised environments. Consequently, pragmatic trials may be less reliable than explanatory trials and may be more susceptible to bias in their design, conduct and analysis. Despite their limitations, pragmatic research can provide valuable information to make decisions in the healthcare context.

The PRECIS-2 tool evaluates the degree of pragmatism within an RCT by scoring it across 9 domains ranging from 1 (very explanatory) to 5 (very pragmatic). In this study, the areas of recruitment, organization and flexibility in delivery, flexible adherence, and follow-up scored high. However, the principal outcome and the method of missing data were scored below the practical limit. This suggests that it is possible to design a trial with high-quality pragmatic features, without damaging the quality of its results.

However, it is difficult to judge how practical a particular trial is since the pragmatism score is not a binary attribute; some aspects of a study can be more pragmatic than others. Furthermore, logistical or protocol modifications made during a trial can change its score on pragmatism. Additionally 36% of 89 pragmatic trials discovered by Koppenaal et al were placebo-controlled, or conducted prior to approval and a majority of them were single-center. They are not in line with the standard practice, and can only be called pragmatic if the sponsors agree that such trials aren't blinded.

Additionally, a typical feature of pragmatic trials is that the researchers attempt to make their findings more relevant by analyzing subgroups of the sample. This can lead to unbalanced results and lower statistical power, thereby increasing the risk of either not detecting or incorrectly detecting differences in the primary outcome. In the case of the pragmatic studies included in this meta-analysis, this was a serious issue since the secondary outcomes were not adjusted to account for 프라그마틱 정품 사이트 differences in baseline covariates.

In addition, pragmatic studies can pose difficulties in the collection and interpretation of safety data. It is because adverse events are typically self-reported, and are prone to delays, inaccuracies or coding errors. It is important to improve the quality and accuracy of outcomes in these trials.

Results

While the definition of pragmatism may not mean that trials must be 100 percent pragmatic, there are benefits of including pragmatic elements in clinical trials. These include:

By including routine patients, the trial results can be translated more quickly into clinical practice. However, pragmatic studies can also have drawbacks. For instance, the right type of heterogeneity could help the trial to apply its findings to a variety of patients and settings; however, the wrong type of heterogeneity could reduce assay sensitivity and therefore decrease the ability of a study to detect minor treatment effects.

A variety of studies have attempted to classify pragmatic trials using different definitions and scoring methods. Schwartz and Lellouch1 developed an approach to distinguish between research studies that prove a physiological or clinical hypothesis, and pragmatic trials that help in the choice of appropriate therapies in clinical practice. The framework was composed of nine domains scored on a 1-5 scale which indicated that 1 was more informative and 5 was more pragmatic. The domains included recruitment, setting up, delivery of intervention, flexible adherence and primary analysis.

The original PRECIS tool3 included similar domains and a scale of 1 to 5. Koppenaal et al10 created an adaptation to this assessment dubbed the Pragmascope that was simpler to use in systematic reviews. They found that pragmatic reviews scored higher on average in all domains, but scored lower in the primary analysis domain.

This distinction in the primary analysis domain could be due to the fact that most pragmatic trials process their data in an intention to treat way while some explanation trials do not. The overall score was lower for pragmatic systematic reviews when the domains of the organization, flexibility of delivery and follow-up were merged.

It is important to note that a pragmatic trial doesn't necessarily mean a poor quality trial, and in fact there is an increasing number of clinical trials (as defined by MEDLINE search, but this is neither sensitive nor specific) which use the word 'pragmatic' in their abstract or title. The use of these terms in abstracts and titles may suggest a greater awareness of the importance of pragmatism, however, it is not clear if this is reflected in the content of the articles.

Conclusions

In recent years, pragmatic trials are becoming more popular in research as the value of real world evidence is becoming increasingly acknowledged. They are clinical trials that are randomized which compare real-world treatment options instead of experimental treatments in development, they have patient populations that more closely mirror the patients who receive routine care, they use comparators that are used in routine practice (e.g., existing drugs) and depend on participants' self-reports of outcomes. This method can help overcome the limitations of observational research like the biases associated with the use of volunteers and the lack of codes that vary in national registers.

Other advantages of pragmatic trials include the ability to use existing data sources, as well as a higher chance of detecting meaningful changes than traditional trials. However, they may have some limitations that limit their credibility and generalizability. For example the rates of participation in some trials may be lower than expected due to the healthy-volunteer influence and incentives to pay or compete for participants from other research studies (e.g., industry trials). The need to recruit individuals in a timely manner also reduces the size of the sample and 프라그마틱 무료슬롯 the impact of many pragmatic trials. Certain pragmatic trials lack controls to ensure that the observed differences aren't due to biases in the trial.

The authors of the Pragmatic Free Trial Meta identified 48 RCTs that self-labeled themselves as pragmatic and were published up to 2022. The PRECIS-2 tool was employed to evaluate the pragmatism of these trials. It covers areas such as eligibility criteria, recruitment flexibility and adherence to intervention and follow-up. They found that 14 trials scored highly pragmatic or pragmatic (i.e. scoring 5 or above) in at least one of these domains.

Trials with a high pragmatism rating tend to have higher eligibility criteria than traditional RCTs that have specific criteria that aren't likely to be present in clinical practice, and they include populations from a wide variety of hospitals. The authors suggest that these traits can make the pragmatic trials more relevant and applicable to everyday clinical practice, however they do not necessarily guarantee that a pragmatic trial is free from bias. In addition, the pragmatism that is present in a trial is not a fixed attribute; a pragmatic trial that doesn't possess all the characteristics of a explanatory trial can yield reliable and relevant results.